A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Intravenous Ketorolac for Pain Management
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|ClinicalTrials.gov Identifier: NCT02078492|
Recruitment Status : Completed
First Posted : March 5, 2014
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: 10 mg of Ketorolac Drug: 15 mg of Ketorolac Drug: 30 mg of Ketorolac||Phase 4|
Ketorolac tromethamine is a non-steroidal anti-inflammatory drug (NSAID) that is widely used in the Emergency Department (ED) for the treatment of moderate-to-severe pain. Ketorolac is available in both oral and parenteral forms and possess significant analgesic potency. However, ketorolac provides few advantages over other currently available analgesics and its use is limited by a virtue of having an "analgesic ceiling" with the dose being 10mg as well as having a range of severe side effects, of which gastrointestinal hemorrhage is most concerning.The concept of an analgesic ceiling is that doses beyond this value (10mg) do not provide additional analgesia and do contribute to side effects. In spite of this, the majority of research conducted on ketorolac in the ED and recommendations in Tintinalli's Emergency Medicine Textbook advocating for use of three-to-six fold higher dosages.
Hypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Intravenous Ketorolac for Pain Management in the Emergency Department"|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Group 1 - 10 mg of Ketorolac
Subjects will be administered 10 mg of Ketorolac for pain relief.
Drug: 10 mg of Ketorolac
Patients will receive 10 mg of Ketorolac for pain control.
Other Name: Toradol
Experimental: Group 2 - 15mg
Subjects will be administered 15mg of Ketorolac.
Drug: 15 mg of Ketorolac
Patients will receive 15mg of Ketorolac for pain control.
Other Name: Toradol
Experimental: Group 3 - 30mg
Subject will receive 30mg of Ketorolac as a part of standard care.
Drug: 30 mg of Ketorolac
Patients will receive 30mg of Ketorolac for pain control.
Other Name: Toradol
- Pain Score at 30 Minutes [ Time Frame: 30 minutes ]Pain score of each group at 30 minutes. The Numeric Rating Pain (NRS) scale was used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). A score of 5 is moderate pain. The higher the pain score the higher the pain severity.
- Adverse Effect of Dizziness [ Time Frame: 120 minutes ]the number of study patients who reported having dizziness after administration of medication.
- Adverse Effect of Nausea [ Time Frame: 120 minutes ]The number of study patients who reported nausea after administration of medication
- Adverse Effect of Headache [ Time Frame: 120 minutes ]The number of study patients who reported headache after administration of medication
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078492
|United States, New York|
|Maimonides Medical Center|
|Brooklyn, New York, United States, 11219|
|Principal Investigator:||Sergey Motov, MD||Attending|